Role Summary:
The Director, Toxicology leads collaboration with non-clinical scientists, and other members of cross-functional matrix teams to support the overall global nonclinical regulatory strategy of Fore Bio products, from research to registration and beyond. This role is responsible for designing and conducting/monitoring toxicology studies at external CROs, interpreting and reporting toxicology findings, and enabling timely high-quality study deliverables. This includes strategic oversight for all aspects of toxicology for the programs including; developing study protocols and reports, and interpreting data from various studies, strategizing nonclinical safety data packages, overseeing safety pharmacology and toxicology studies, leading risk mitigation strategies, maintaining expertise on current and emerging technologies and approaches in toxicology and advising strategies for implementation, where appropriate.
The candidate will also be responsible for writing nonclinical sections of regulatory documents (e.g., pre-IND packages, INDs/CTAs, BLAs/NDAs, Investigator Brochures), risk assessment documents, etc. and interactions with regulatory agencies.
Essential Duties and Responsibilities
:
- Designs toxicology and safety pharmacology studies to support research and development programs.
- Manages and monitors nonclinical studies (GLP and non-GLP) at external CROs and ensures that global regulatory/compliance requirements are met/exceeded.
- Critically reviews and edits CRO nonclinical toxicology study reports, analyzes and interprets data, defines PK/PD and PK/Toxicity correlations, partners in PK modeling and parameter estimation, and coordinates reports’ finalization with CROs upon internal review and team communication, ensuring consistency with global regulatory and compliance requirements.
- Drafts nonclinical sections for IND/CTA and NDA/BLA submissions and other regulatory documents (e.g., IB, DSUR, PSUR, Scientific Advice, annual reports, and briefing documents etc.) to ensure regulatory compliance
- Provides critical input to project teams and senior management on discovery and nonclinical development strategy including peer review of pharmacology/pharmacokinetic protocols, reports, and regulatory content.
- Leads and/or participates in cross functional teams as early development expert to ensure proper integration of these activities into overall project plans.
- Partners with and provides subject matter expertise to key internal functions (regulatory, Quality, Clinical, CMC and formulations, Product Quality, Drug safety, Medical affairs, Program Management) and their external contractors or collaborators to drive the overall development strategy and timeline of the asset
- Provides strategic input regarding the potential impact of toxicology results on Program and Clinical/Regulatory strategy
- Provides strategic direction on toxicology from discovery throughout market application for the program, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards
- Maintains a current understanding of relevant literature and methodology, as well as the scientific literature related to Fore Bio products and R&D projects
- Contribute to department SOPs and best practice documents
Education and/or Work Experience Requirements:
- Ph.D. in Toxicology, Pharmacology, Pathology, Biochemistry or Biology with a minimum of 10 years of experience in the pharmaceutical or biotechnology industry.
- Board certification (e.g., DABT, ERT) is highly desirable
- Experience in outsourcing and monitoring toxicology studies, CRO management, and interacting with study directors and other vendors (e.g., consultants) to obtain timely delivery of clear, accurate, and well-written toxicology study reports with defensible data analyses and data interpretation. Capacity to synthesize and communicate complex information. Capacity to propose practical mitigation (de-risking) strategies.
- Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations for nonclinical drug development IND experience is required.
- Experience in authoring non-clinical elements of major regulatory submissions (INDs, CTAs, BLA/NDAs or sNDAs) and other regulatory documents (e.g., IB, PSUR, DSUR); preparing science-based responses to regulatory questions.
- Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical safety assessment activities to support drug candidates’ success at all stages of development.
- Ability to synthesize, interpret and integrate diverse, multidisciplinary scientific data (e.g., pharmacology, pharmacokinetics, pathology).
- Experience in Discovery Toxicology as applicable to early stages (non IND-enabling) drug development would be a plus.
- Proven track record of successfully leading toxicology programs through various stages of drug development.
- Advanced knowledge of toxicology, pharmacology, safety pharmacology & DMPK. Advanced knowledge of scientific methods and techniques related to the nonclinical data, pertinent laws, regulations, and HA.
- Excellent verbal communication and scientific writing skills as applied to study reports and regulatory documents. Ability to interact effectively and tactfully with a variety of critical audiences within and outside the organization and with regulatory agency representatives. Sense of urgency.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
Fore Bio provides equal employment opportunities (EEO) to all employees and applicant for employment without regard to religion, race, creed, color, sex orientation, national origin, age, marital status or any other characteristic protected by applicable federal, state, or local law.
